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Solvent for Residual Solvent Analysis

Residual solvents in pharmaceuticals are classified into Class 1 to Class 3 according to the ICH guidelines on residual solvents in pharmaceuticals (ICH Q3C), based on the risk that may affect human health, and are strictly controlled. The Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP) specify a highly sensitive analytical method using headspace gas chromatography (HS-GC) as a method for testing residual solvents in pharmaceuticals. However, some of commercial solvents contain other impurity / residual solvents (low-boiling compounds). When you use a solvent for which no residual solvent is guaranteed and a solvent peak is detected, it is not clear whether the peak is derived from a sample or solvent, and it may be impossible to obtain accurate results. Solvents "for Residual Solvent Analysis" of FUJIFILM Wako is a series of solvents that reduce and guarantee residual solvents in the solvents. 2 types of series are available. One is a "for ICH Q3C Analysis" with guaranteed residual solvents listed in ICH Q3C Classes 1 to 3, and the other is a series with guaranteed 4 types of residual solvents selected by FUJIFILM Wako.

for Residual Solvent Analysis
(for ICH Q3C Analysis)
for Residual Solvent Analysis
Guaranteed Solvents Solvent species listed in ICH Q3C Classes 1 to 3* The 4 types of solvents selected by FUJIFILM Wako (Acetone, Ethanol, Methanol, and Hexane)

*Some solvents are not guaranteed. For details, see the specifications.

for Residual Solvent Analysis (for ICH Q3C Analysis)

Impurity / residual solvents (low-boiling compounds) in solvents are reduced.

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59 types of residual solvents listed in ICH Q3C Classes 1 to 3 are guaranteed.

In addition to the guaranteed solvents of “for residual solvent Analysis” grade, the following solvents listed in ICH Q3C Classes 1 to 3 are guaranteed.

▼Class 1 (max. 1 ppm)

Carbon tetrachloride 1,2-Dichloroethane 1,1-Dichloroethene 1,1,1-Trichloroethane Benzene

 

▼Class 2 (max. 10 ppm)*1

Acetonitrile Ethylbenzene 2-Ethoxyethanol o-, m-, p-Xylene Chlorobenzene
Cumene*2 Chloroform Cyclohexane 1,2-Dichloroethene 1,4-Dioxane
Dichloromethane N,N-Dimethylacetamide N,N-Dimethylformamide 1,2-Dimethoxyethane Sulfolane
Tetrahydrofuran*2 Tetralin Toluene 1,1,2-Trichloroethene Nitromethane
Pyridine Hexane Methanol Methyl isobutyl ketone*2 Methylcyclohexane
N-Methylpyrrolidone Methylbutyl ketone 2-Methoxyethanol

*1: Ethylene glycol and formamide are not guaranteed.
*2: Guaranteed at max. 50 ppm

 

▼Class 3 (max. 50 ppm)*3

Acetone Anisole Ethanol Ethyl formate Acetic acid
Isobutyl acetate Isopropyl acetate Ethyl acetate n-Butyl acetate Propyl acetate
Methyl acetate Diethyl ether Dimethylsulfoxide 1-Butanol 2-Butanol
t-Butylmethyl ether 1-Propanol 2-Propanol Heptane 1-Pentanol
Pentane Methyl ethyl ketone 3-Methyl-1-butanol 2-Methyl-1-propanol

*3: Formic acid and triethylamine are not guaranteed.

for Residual Solvent Analysis

Solvents that reduce residual solvents in the solvents and guarantee that the following 4 types of solvents are not more than 0.1 ppm

▼Guaranteed Solvents (max. 0.1 ppm)

Acetone Ethanol Methanol Hexane

*The guaranteed solvents are different from those “for residual solvent Analysis (for ICH Q3C Analysis)”.

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for Residual Solvent Analysis (for ICH Q3C Analysis)

1,3-Dimethyl-2-imidazolidinone for ICH Q3C

for Residual Solvents Analysis

Manufacturer :
FUJIFILM Wako Pure Chemical Corporation
Storage Condition :
Keep at RT.
GHS :

Comparison
Product Number
Package Size
Price
Availability
Purchase
Distributor
049-34725
500mL
Inquire

In stock in Japan

for Residual Solvent Analysis

N,N-Dimethylacetamide

for Residual Solvents Analysis

Manufacturer :
FUJIFILM Wako Pure Chemical Corporation
Storage Condition :
Keep at RT.
GHS :
Outline :
This product is for research use only. Do not administer it to human.

This product is a highly pure solvent that hardly contains low-boiling point compounds detectable by gas chromatography.

Comparison
Product Number
Package Size
Price
Availability
Purchase
Distributor
041-31561
3L
List Price
311.00 USD

In stock in Japan

Distributor
043-31565
500mL
List Price
63.00 USD

In stock in Japan

1,3-Dimethyl-2-imidazolidinone

for Residual Solvents Analysis

Manufacturer :
FUJIFILM Wako Pure Chemical Corporation
Storage Condition :
Keep at RT.
GHS :
Outline :
This product is for research use only. Do not administer it to human.


This product is a high-quality solvent that has been proven by gas chromatography to contain almost no low-boiling point impurities.

Comparison
Product Number
Package Size
Price
Availability
Purchase
Distributor
042-33311
3L
List Price
396.00 USD

In stock in Japan

Distributor
044-33315
500mL
List Price
105.00 USD

In stock in Japan

Dimethyl Sulfoxide

for Residual Solvents Analysis

Manufacturer :
FUJIFILM Wako Pure Chemical Corporation
Storage Condition :
Keep at RT.
GHS :
Outline :
This product is for research use only. Do not administer it to human.DMSO is used as an extractant in the residual solvent test established by the Japanese Pharmacopoeia. This product is a high-quality solvent that has been proven by gas chromatography to contain almost no low-boiling point impurities.

Comparison
Product Number
Package Size
Price
Availability
Purchase
Distributor
049-31361
3L
List Price
319.00 USD

In stock in Japan

Distributor
045-31363
100mL
List Price
39.00 USD

In stock in Japan

Distributor
041-31365
500mL
List Price
63.00 USD

In stock in Japan

N,N-Dimethylformamide

for Residual Solvents Analysis

Manufacturer :
FUJIFILM Wako Pure Chemical Corporation
Storage Condition :
Protect from light.
GHS :
Outline :
This product is for research use only. Do not administer it tovhuman.

This is a highly pure solvent with negligible low-boiling point chemicalvcompounds detectable by the gas chromatography.

Comparison
Product Number
Package Size
Price
Availability
Purchase
Distributor
044-31551
3L
List Price
319.00 USD

In stock in Japan

Distributor
046-31555
500mL
List Price
65.00 USD

In stock in Japan

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Japanese Pharmacopoeia Residual Solvents Class2A RS
Manufacturer :
Pharmaceutical and Medical Device Regulatory Science Society of Japan
Storage Condition :
Keep at RT.
GHS :

Comparison
Product Number
Package Size
Price
Availability
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Distributor
638-37771
Manufacturer
1059800021
1.2mL x3
Inquire

Out of Stock

Japanese Pharmacopoeia Residual Solvents Class 2B RS
Manufacturer :
Pharmaceutical and Medical Device Regulatory Science Society of Japan
Storage Condition :
Keep at RT.
GHS :

Comparison
Product Number
Package Size
Price
Availability
Purchase
Distributor
635-37781
Manufacturer
1059850021
1.2mL x3
Inquire

Out of Stock

Japanese Pharmacopoeia Residual Solvents Class2C RS
Manufacturer :
Pharmaceutical and Medical Device Regulatory Science Society of Japan
Storage Condition :
Keep at RT.
GHS :

Comparison
Product Number
Package Size
Price
Availability
Purchase
Distributor
634-48121
Manufacturer
1059860021
1.2mL x3
Inquire

Out of Stock

Japanese Pharmacopoeia Residual Solvents RS for System Suitability RS
Manufacturer :
Pharmaceutical and Medical Device Regulatory Science Society of Japan
Storage Condition :
Keep at RT.
GHS :

Comparison
Product Number
Package Size
Price
Availability
Purchase
Distributor
632-31951
Manufacturer
1059900021
1.2mL x3
Inquire

Out of Stock

Author: A. Samoveanu

For research use or further manufacturing use only. Not for use in diagnostic procedures.

Product content may differ from the actual image due to minor specification changes etc.

If the revision of product standards and packaging standards has been made, there is a case where the actual product specifications and images are different.